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Completed

NCT Number: NCT00790920

Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke

The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3-9 hours from onset of stroke symptoms.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

AU006, Clayton, Australia

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About this study

Acute stroke is a major cause of mortality and long-term disability in the developed world. The only currently approved thrombolytic intervention for acute ischemic stroke, which constitutes the majority of strokes, is alteplase (recombinant tissue plasminogen activator; rtPA). The use of alteplase is limited as it is approved for use within 3 hours after symptom onset and by the risk of inducing intracerebral haemorrhage; consequently fewer than 3% of acute stroke subjects are treated. The thrombolytic agent desmoteplase (recombinant Desmodus Salivary Plasminogen Activator alpha-1; rDSPAalpha-1) produced by recombinant biotechnology has its naturally occurring counterpart in the saliva of the vampire bat Desmodus rotundus. Compared to alteplase, desmoteplase has a more favourable profile in terms of high fibrin specificity and non neurotoxicity.

The study aims to confirm efficacy and safety of desmoteplase for thrombolytic therapy of patients with acute ischaemic stroke in the extended time window of 3-9 hours after onset of stroke symptoms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of acute ischemic stroke
  • Informed consent
  • Age between 18 and 85 years
  • Treatment can be initiated within 3-9 hours after the onset of stroke symptoms
  • NIHSS Score of 4-24
  • Vessel occlusion or high-grade stenosis on MRI or CTA in proximal cerebral arteries

Exclusion criteria

  • Pre-stroke mRS >1
  • Previous exposure to desmoteplase
  • Extensive early infarction on MRI or CT in any affected area
  • Imaging evidence of ICH or SAH; AV malformation; cerebral aneurysm; or cerebral neoplasm
  • Internal carotid artery occlusion on the side of the stroke lesion
  • Treatment with heparin in the past 48 hours and a prolonged partial thromboplastin time
  • Treatment with oral anticoagulants and a prolonged prothrombin time
  • Treatment with glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single agent oral platelet inhibitors is permitted
  • Treatment with a thrombolytic agent within the past 72 hours

Treatment and study plan

Desmoteplase

Drug

90 μg/kg bodyweight, IV, single bolus over 1 - 2 minutes on 1st day

Placebo

Drug

IV, single bolus over 1 - 2 minutes on 1st day

Primary outcomes

  1. Modified Rankin Scale Score

    Time frame: 90 days

Secondary outcomes

  1. National Institutes of Health Stroke Scale (NIHSS) Score

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

A Randomised, Double-blind, Parallel-group Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Desmoteplase in Subjects With Acute Ischemic Stroke

Acronym: DIAS-3

Important dates

Study start
2008
Primary completion
2014
First posted
Nov 14, 2008
Registry last updated
Sep 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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